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A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01527383
First received: January 16, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with autoimmune disease.


Condition Intervention Phase
Herpes Zoster
 Biological: V212
Biological: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Geometric mean fold rise in varciella-zoster virus (VZV) antibody response as measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) [ Time Frame: Approximately 28 days postdose 4 ] [ Designated as safety issue: No ]
  • Geometric mean fold rise in the VZV-specific immune responses measured by VZV interferon-gamma (IFN-g) ELISPOT [ Time Frame: Approximately 28 days postdose 4 ] [ Designated as safety issue: No ]
  • Incidence of serious adverse events [ Time Frame: Through 28 days postdose 4 ] [ Designated as safety issue: Yes ]

Enrollment: 354
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V212 Biological: V212
V212 viral antigen for Herpes Zoster (HZ), 0.5 mL subcutaneous injection per dose, in a 4-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Other Name: Inactivated VZV vaccine
Placebo Comparator: Placebo Biological: Placebo
Vaccine stabilizer for V212 with no virus antigen, 0.5 mL subcutaneous per dose, in a 4-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

Detailed Description:

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including patients with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with an autoimmune disease
  • Clinically stable disease for at least 30 days before enrollment
  • Not likely to undergo hematopoietic stem cell transplantation during the study period
  • Receiving at least one parenteral or oral biologic agent, such as a TNF alpha inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at least 3 months, with no planned or anticipated changes
  • History of varicella, antibodies to VZV, or residence for at least 30 years in a country with endemic VZV infection, or if participant is less than 30 years old, attended primary or secondary school in a country with endemic VZV infection

Exclusion Criteria:

  • Prior history of Herpes Zoster (shingles) within 1 year before enrollment
  • Prior varicella or zoster vaccine
  • Active central nervous system lupus erythematosus requiring therapeutic intervention within 90 days of enrollment
  • Prior or planned therapy containing rituximab or other anti-CD20 monoclonal antibodies from 3 months before enrollment through 28 days postdose 4
  • Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the time of enrollment
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01527383     History of Changes
Other Study ID Numbers: V212-009
Study First Received: January 16, 2012
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Shingles

Additional relevant MeSH terms:
Autoimmune Diseases
Herpes Zoster
Immune System Diseases
 Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013